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Abstract:

An insulin injection pen and blood glucose monitoring device is
integrated into a single unit that fits in a user's clothing pocket or
handbag. The device includes a blood glucose monitoring system for
detecting the user's blood glucose level, an insulin injection mechanism,
and a microprocessor that calculates an insulin dosage appropriate to the
detected blood glucose level of a particular user and sets the insulin
injection mechanism to administer the calculated insulin dosage. The
device automatically informs a remote emergency service provider if the
microprocessor determines that the detected blood glucose level presents
a potential danger to the user. The microprocessor also calculates
treatment regimens based on the detected blood glucose level and displays
the treatment regimens on an LCD display. The device can include a GPS
receiver that detects the location of the device, which is transmitted by
the device to the remote emergency service.

Claims:

1.-16. (canceled)

17. A portable blood glucose monitoring device and insulin administering
pen integrated into a single unit for testing and treating diabetes
symptoms in a user, the unit comprising: a housing of a size suitable for
transport in a handbag or clothing pocket of the user; a blood glucose
monitoring system in said housing for receiving a sample of the user's
blood, said blood glucose monitoring system being operable to detect the
glucose level in the blood sample; an insulin administration mechanism in
said housing for administering an insulin dosage to the user; a
microprocessor in said housing for determining if the detected blood
glucose level is above a predetermined threshold indicating that the user
is in potential danger and calculating an insulin dosage appropriate to
the detected blood glucose level, wherein said insulin administration
mechanism is operable to provide a signal to said microprocessor
indicating that an insulin dosage has been administered; a display on
said housing for displaying to the user at least one of the detected
blood glucose level and the calculated insulin dosage; and a
communication device in said housing and under the control of said
microprocessor for automatically informing a remote emergency service
provider of a hypoglycemic condition of potential danger to the user if
said microprocessor (i) determines that the detected blood glucose level
is above the predetermined threshold, and (ii) fails to receive said
signal from said insulin administration mechanism within a predetermined
time interval after said microprocessor determines that the blood glucose
level is above the predetermined threshold.

18. A device as in claim 17, further comprising: a mode switch in said
housing having a first state for actuating said blood glucose monitoring
system to cause detection of the glucose level in the received blood
sample and a second state for administering an insulin dosage; and at
least one manual input device operable by the user in conjunction with
information displayed on said display for providing a user interface
permitting the user to set an insulin dosage that is changed from the
calculated insulin dosage displayed on said display, wherein when said
mode switch is in said second state said insulin administration mechanism
is operable to administer the different insulin dosage if the calculated
insulin dosage has been changed and to administer the calculated insulin
dosage if it has not been changed.

19. A device as in claim 18, said mode switch being manually operable
between its first and second states and said unit further comprising a
sensor for sensing when said administration mechanism is in place for
administering insulin, wherein manually setting said mode switch to the
second state automatically provides a signal to said microprocessor to
cause said insulin administering mechanism to administer an insulin
dosage when said sensor indicates that said administering mechanism is in
place.

20. A device as in claim 19, wherein said insulin administration
mechanism includes a hypodermic needle for injecting the insulin dosage
and said sensor senses when said needle has penetrated the skin of the
user.

21. A device as in claim 19, wherein said mode switch has a neutral state
and said microprocessor displays a prompt on said display instructing the
user to take a blood sample and detect the glucose level thereof when
said mode switch is moved from its neutral state to its first state.

22. A device as in claim 19, wherein receipt by said microprocessor of a
signal from said sensor when said switch is in the second state changes
said display to indicate a time interval after which the insulin dosage
will be automatically administered.

23. A device as in claim 22, wherein said insulin administration
mechanism includes a hypodermic needle for injecting the insulin dosage
and said sensor senses when said needle has penetrated the skin of the
user.

24. A device as in claim 18, wherein said microprocessor further includes
dose lock software that causes said display to display a prompt requiring
the user to confirm the desire to change the amount of insulin to be
administered before permitting said insulin administration mechanism to
administer the amount of insulin input by the user.

25. A device as in claim 18, wherein: said device stores information
regarding a particular user's treatment requirements and said
microprocessor determines treatment regimens specific to the particular
user based on the detected blood glucose level and the stored
information; said treatment regimens include (i) ingestion of at least
one blood glucose producing substance, if the detected blood glucose
level indicates that the user is hypoglycemic, and (ii) administration of
insulin, lithe detected blood glucose level indicates that the user is
hyperglycemic; and said microprocessor causes said display to indicate
(i) an amount of the at least one blood glucose producing substance to be
consumed, lithe detected blood glucose level indicates that the user is
hypoglycemic, or (ii) the calculated insulin dosage, if the detected
blood glucose level indicates that the user is hyperglycemic, or (iii)
the different insulin dosage if the calculated insulin dosage has been
changed.

26. A device as in claim 17, wherein said communication device includes a
cellular telephone and the remote emergency service provider is at least
one of a public emergency service provider and an emergency service to
which the user has subscribed.

27. A device as in claim 26, wherein said communication device is at
least one of (i) a cellular telephone separate from said housing and
circuitry within said housing for establishing a wireless connection to
said cellular telephone, and (ii) cellular telephone circuitry within
said housing.

28. A device as in claim 17, further comprising circuitry in said housing
for detecting the location of the device, wherein said communication
device transmits information regarding the location to the remote
emergency service provider.

29. A device as in claim 28, wherein said circuitry for detecting the
location of the device comprises a GPS receiver.

30. A device as in claim 17, wherein said device stores information
regarding a particular user's treatment requirements and said
microprocessor determines treatment regimens specific to the particular
user based on the detected blood glucose level and the stored information
and displays the treatment regimens on said display.

31. A device as in claim 30, wherein said treatment regimens include:
ingestion of at least one blood glucose producing substance in an amount
calculated by said microprocessor based on the detected blood glucose
level, if the detected blood glucose level indicates that the user is
hypoglycemic; and administration of the calculated insulin dosage
determined by said microprocessor based on the detected blood glucose
level, if the detected blood glucose level indicates that the user is
hyperglycemic.

32. A medication administering device comprising: a housing of a size
suitable for transport in a handbag or clothing pocket of a user; a
medication administration mechanism in said housing for administering to
the user a dosage of a medication contained in said housing; circuitry in
said housing for controlling said medication administration mechanism;
and a sensor for sensing when said administration mechanism is in place
for administering a dosage, wherein said sensor automatically provides a
signal to said circuitry to cause said medication administering mechanism
to administer a dosage when said sensor indicates that said administering
mechanism is in place.

33. A device as in claim 32, further comprising a display on said
housing, wherein said display indicates a time interval after which the
medication dosage will be automatically administered.

34. A device as in claim 32, further comprising: a manually operable mode
switch movable by a user between a first state and a second state,
wherein said circuitry is responsive to said mode switch for disabling
said medication administration mechanism when said switch is in said
first state and permitting said medication administration mechanism to
administer a dosage when said switch is in said second state; a manual
input device operable by the user to set a dosage to be administered by
the medication administration mechanism; and a display on said housing
for providing a user interface displaying to the user the dosage input by
said manual input device.

35. A device as in claim 34, wherein receipt by said circuitry of a
signal from said sensor when said switch is in the second state changes
said display to indicate a time interval after which the medication
dosage will be automatically administered.

36. A device as in claim 34, wherein: said circuitry includes a
microprocessor for determining a medication dosage appropriate to
information relating to the user that has been provided to said
microprocessor; said display initially displays to the user the dosage
determined by said microprocessor; and said manual input device is
operable by the user in conjunction with the determined dosage displayed
on said display for permitting the user to set a medication dosage that
is changed from the determined dosage and display the changed dosage on
the display, wherein when said mode switch is in said second state said
medication administration mechanism is operable to administer the
different dosage if the determined dosage has been changed and to
administer the determined dosage if it has not been changed.

37. A device as in claim 36, wherein said microprocessor further includes
dose lock software that causes said display to display a prompt requiring
the user to confirm the desire to change the dosage before permitting
said medication administration mechanism to administer the dosage input
by the user.

38. A device as in claim 37, wherein said medication administration
mechanism includes a hypodermic needle for injecting the medication and
said sensor senses when said needle has penetrated the skin of the user.

39. A device as in claim 32, wherein said medication administration
mechanism includes a hypodermic needle for injecting the medication and
said sensor senses when said needle has penetrated the skin of the user.

40. A device as in claim 32, wherein the medication is insulin.

Description:

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to managing diabetes symptoms, and
more particularly, to a device and method for controlling diabetes
symptoms and monitoring a diabetes patient.

[0003] 2. Description of Related Art

[0004] The prior art includes devices for monitoring blood glucose levels
of diabetes patients and devices for administering insulin to control
blood glucose levels. Known blood glucose monitors take many forms. For
example, one type of monitor is implanted in a patient and transmits
blood glucose readings to an external display more or less continuously.
Other devices require the patient to take periodic blood samples for
analysis by the glucose monitor. In the latter type of device the patient
typically lances a finger and places a blood sample on a medium such as a
test strip. The monitor analyzes the test strip and provides a digital
readout of the blood glucose level on a monitor display.

[0005] Depending on the patient's blood glucose level, it may or may not
be necessary to administer a dose of insulin. Insulin delivery devices
also take many forms. Broadly speaking, insulin delivery can be either
essentially automatic by permanently attaching the patient to an insulin
pump, or as-needed by using an injection device (such as a hypodermic
needle) with which the patient injects an amount of insulin determined
according to a predetermined protocol when the measured blood glucose
level is outside an acceptable range.

[0006] Many devices and systems seek to automate diabetics' blood glucose
control protocols by computerizing conventional devices so that insulin
dosages can be automatically determined and delivered with minimum
intervention by the patient. The following references illustrate some
typical examples of such devices and systems:

[0007] Devices disclosed in U.S. Pat. No. 5,728,074 embody the "as-needed"
type of insulin delivery approach. Some of these disclosed devices could
be particularly useful because they provide a variety of functions that a
diabetic would undoubtedly find helpful in managing his or her disease.
For example, the disclosed embodiments include devices that combine an
insulin injection mechanism and a blood glucose monitor, such as the
"pen-type injector" depicted in FIG. 25. This device has at one end a
removable cap that conceals a hypodermic needle for insulin injection and
a lancet mechanism used by the patient to prick a finger to obtain a
blood sample for analysis by a test strip on the injector housing. U.S.
Patent Pub. No. 2010/0010330 exemplifies the type of system that employs
a blood glucose sensor implanted in the patient to provide continuous
glucose level data to a bedside monitoring system that controls an
insulin infusion pump. The system can include software that determines if
the patient's blood glucose level is at a dangerously low level and can
alert 911 or other medical emergency response provider. While this
feature enhances patient safety, it has a significant drawback in that
the patient is tethered to the monitoring system.

[0008] Many diabetics lead relatively active lives, and for them being
tethered to a monitoring system is obviously not acceptable. These
patients require a treatment regimen that enables them to maintain a
normal lifestyle by minimizing limitations that might otherwise be
imposed by their diabetes. Even though existing devices and systems
permit such patients to closely monitor their own blood glucose levels,
and thus minimize the risk of becoming hypoglycemic or hyperglycemic at
any given time, a diabetes patient still can experience either condition
without much warning. Hypoglycemia can be particularly dangerous because
it can impair cognitive functions, so a patient with a low blood glucose
level can become disoriented and confused very rapidly. If the patient's
blood glucose level is not corrected in time, he or she can lapse into a
coma and even die before being able to take necessary corrective action.
By the same token, hyperglycemia, while less likely than hypoglycemia to
present an emergency situation, can nonetheless be dangerous.
Accordingly, devices that rely on the patient to take appropriate steps
after determining his or her own blood glucose level would have greater
utility if they could automatically take action to preempt the
potentially serious consequences of rapid changes in blood glucose
levels.

SUMMARY OF THE INVENTION

[0009] It is an object of the present invention to improve on known
techniques involving self-administration of appropriate therapy to adjust
glucose levels after a patient tests his or her own blood glucose level.
One important aspect of the invention provides an automatic alert to an
emergency service provider if a patient using a device for self-testing
his or her own blood glucose level does not respond to prompts and thus
may be in need of immediate medical attention.

[0010] In accordance with a first aspect of the invention, a portable
blood glucose monitoring device and insulin injection pen integrated into
a single unit for testing and treating diabetes symptoms in a user
comprises a housing of a size suitable for transport in a handbag or
clothing pocket of the user, a blood glucose monitoring system within the
housing for receiving a sample of the user's blood and detecting the
glucose level thereof, an insulin injection mechanism within the housing
for permitting the user to self administer an insulin injection, a
microprocessor within the housing for calculating an insulin dosage
appropriate to the detected blood glucose level and setting the insulin
injection mechanism to administer the calculated insulin dosage, a
display mounted on the housing for displaying the detected blood glucose
level and the calculated insulin dosage, and a communication device
within the housing and under the control of the microprocessor for
automatically informing a remote emergency service provider if the
microprocessor determines that the detected blood glucose level presents
a potential danger to the user.

[0011] In accordance with more specific embodiments of the invention, such
a unit further comprises at least one manual input device operable by the
user in conjunction with information displayed on the display for
providing a user interface for permitting the user to control
predetermined operations of the unit. A particularly advantageous
embodiment comprises a GPS receiver within the housing for detecting the
location of the device, wherein the communication device transmits
information regarding the location to the remote emergency service.

[0012] An additional aspect of the invention includes a method of
monitoring a diabetes patient including providing a portable blood
glucose monitoring device comprising a housing of a size suitable for
transport in a handbag or clothing pocket of the patient, the housing
having therein a blood glucose monitoring system for receiving a sample
of the patient's blood and detecting the glucose level thereof, a storage
device for storing a threshold representing a blood glucose level of
potential danger to the patient, a GPS receiver for detecting the
location of the device, and a communication device for contacting a
remote emergency service provider, introducing to the blood glucose
monitoring system a sample of the user's blood, comparing the detected
blood glucose level of the sample to the threshold blood glucose level,
and if the detected level is past the threshold, automatically activating
the communication device to transmit a message to the emergency service
provider including information on the potentially dangerous condition of
the user and information regarding the location of the device.

[0013] In accordance with more specific method aspects of the invention,
the storage device stores a first threshold representing a blood glucose
level below which the patient is severely hypoglycemic and may be
disoriented or comatose, and a second threshold above which the patient
is severely hyperglycemic and may require immediate medical intervention,
and the method further includes setting a time period by which the
patient must provide an input to the monitoring device if the detected
blood glucose level is below the first threshold or above the second
threshold before automatically activating the communication device. In
another variation, the monitoring device further comprises an insulin
injection mechanism within the housing for permitting the user to self
administer an insulin injection, and the method further includes
determining if the detected blood glucose level indicates that the
patient is hypoglycemic or hyperglycemic, and if the patient is
hypoglycemic, instructing the patient to ingest an amount of at least one
blood glucose producing substance based on the detected blood glucose
level, or if the patient is hyperglycemic, calculating an insulin dosage
appropriate to the detected blood glucose level and using the insulin
injection mechanism to set an amount of insulin to be injected based on
the detected blood glucose level.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The objects of the invention will be better understood from the
detailed description of its preferred embodiments which follows below,
when taken in conjunction with the accompanying drawings, in which like
numerals and letters refer to like features throughout. The following is
a brief identification of the drawing figures used in the accompanying
detailed description.

[0015] FIGS. 1A and 1B are perspective views showing the four sides of a
unitary integrated blood glucose monitor and insulin injection pen
according to an embodiment of the present invention.

[0016] FIGS. 2A and 2B schematically depict a lancet and blood glucose
test strip that form a part of a blood glucose monitoring system that is
integrated into the blood glucose monitor and insulin pen unit shown in
FIG. 1.

[0017]FIG. 3 partially depicts in schematic fashion an insulin injection
mechanism with a hypodermic needle that forms a part of the insulin pen
and blood glucose monitor unit shown in FIG. 1.

[0018]FIG. 4 is a simplified block diagram showing the system components
for an blood glucose monitor and insulin pen unit according to one
embodiment of the present invention such as that shown in FIGS. 1 to 3.

[0019] FIG. 5 illustrates an embodiment of a user interface with an LCD
display and manual input devices incorporated into the unit shown in FIG.
1.

[0020] FIG. 6, comprising FIGS. 6A, 6B and 6C, is a flowchart depicting
the steps in a blood glucose test and insulin injection cycle according
to an embodiment of the present invention.

[0021]FIG. 7 illustrates a display mode of the LCD display shown in FIG.
5 in which it can display numeric fields indicating a blood glucose
level, insulin dosage, and other information.

[0022] FIG. 8 illustrates a display mode of the LCD display shown in FIG.
5 in which it can display messages to the user.

[0023] One skilled in the art will readily understand that the drawings
are not strictly to scale, but nevertheless will find them sufficient,
when taken with the detailed descriptions of preferred embodiments that
follow, to make and use the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0024] FIGS. 1A and 1B show an integrated blood glucose monitor and
insulin pen unit 10 in accordance with one embodiment of the invention.
The integrated monitor/pen unit 10 has an elongated, generally
rectangular housing 12 most conveniently provided in a one-piece molded
plastic construction. A cap 14 fits onto the housing 12 at one end to
conceal a hypodermic needle (not shown in FIG. 1) that forms a part of an
insulin injection mechanism described in more detail further below. The
cap 14 is also conveniently molded from a suitable plastic material in
one piece, and fits snugly onto the end of the housing 12 either by
friction or by a snap fit, to prevent inadvertent removal of the cap and
consequent exposure of the hypodermic needle. A blood glucose monitoring
system 16 also includes a cap that fits snugly onto the other end of the
housing 12. Further details of the blood glucose monitoring system and
the insulin injection mechanism are described below in connection with
FIGS. 2 and 3.

[0025] When the caps are in place on the housing 12, these parts together
form a cylinder with a rectangular cross section that has substantially
constant dimensions along its entire length and has a unitary appearance.
The cross section can have rounded corners, which will give the unit 10 a
compact appearance and facilitate handling by a user. The elongated
configuration of the housing enables the various mechanical and
electronic components of the monitor/pen unit 10 to be contained in a
compact device that is easily carried in a pocket or handbag/purse. To
that end, a preferred unit will have a cross section about
1.0''×0.5'' and be about 5'' to 6'' long. Other configurations and
dimensions can be used within the broadest scope of the invention. For
example, one skilled in the art may chose to arrange the internal
components of the unit discussed below in a manner that makes it
preferable to use a different configuration or a different size.

[0026] The unit 10 further includes various components for receiving
inputs from a user and communicating outputs to the user or to other
destinations, as described further below. A speaker 18 enables the unit
to provide voice commands or prompts to the user, and a microphone 20
enables the user to communicate with the unit by voice. A USB port 22
enables communications between the unit and associated peripheral
devices, as well as permitting uploading of information to a memory in
the unit and downloading information from the memory. On an adjacent side
of the housing a removable cover 24 provides access to the insulin
injection mechanism within the housing for purposes described below. On
the same side, a battery compartment with a removable cover 26 accepts
batteries of a suitable rating for providing operating power to the unit.
The batteries can be rechargeable, and recharging can be accomplished by
attaching a suitable power cord to the USB port. This side of the housing
12 can be considered the rear of the unit since the covers 24 and 26 are
accessed relatively infrequently. The covers 24 and 26 are placed on the
longer side of the unit's rectangular cross section to facilitate their
manipulation by a user. This side of the unit also includes an ON-OFF
switch 28 for powering the unit on and off. (In describing embodiments of
the invention, terms indicating direction or orientation, such as
"front," "rear," "right," "left," etc., may be used to facilitate the
description. They do not imply that the invention is limited to a
particular orientation of the pen/monitor unit.)

[0027] FIGS. 2A and 2B are schematic representations of an exemplary
embodiment of the blood glucose monitoring system 16. FIG. 2B shows a
lancet 30 extending from the inside of a glucose monitoring system cap 32
that fits snugly on the end of the housing 12 as discussed above. The
lancet 30 is essentially a very sharp needle typically made of surgical
grade stainless steel. The patient pricks a finger with the lancet to
draw a sufficient quantity of blood for glucose level testing. FIG. 2A
shows the end of the housing 12 from which extends a glucose test strip
33 onto which the user places a blood sample by touching the lanced
finger to the strip. The strip then introduces the blood by capillary
action into conventional testing apparatus within the unit that
determines the blood's glucose level. The details of the glucose level
testing do not form a part of the present invention, and are well known
to those skilled in the art. U.S. Pat. No. 5,728,074 mentioned above
describes various ways of performing such testing and obtaining a
corresponding electrical signal. Any of those techniques, or variations
thereof, can be used in performing blood glucose testing with the unit
10, and those portions of U.S. Pat. No. 5,728,074 describing such testing
are incorporated by reference as if set out in full herein. Many of the
other patents discussed above also describe ways of testing blood glucose
levels, and unit 10 could use any of those techniques as well.

[0028] Although the manner in which the patient's blood glucose level is
determined is conventional, the configuration of the blood glucose
testing system 16 shown in FIGS. 2A and 2B is particularly advantageous
from the standpoint of a user of the unit 10. The cap 32 has an internal
shoulder 34 that fits over a corresponding external shoulder 36 on the
housing 12. The internal shoulder 34 includes a circumferential groove
34a that accepts a circumferential ridge 36a on the external shoulder 36.
The groove 34a and ridge 36a provide a snap fit to positively hold the
cap 32 on the housing 12 The outside peripheral surfaces of the cap 32
and housing 12 are flush in order to maintain the unitary appearance of
the unit 10 when the cap is in place on the housing. A lancet 30 and test
strip 33 are each typically used only once and then discarded. The cap 32
can be made hollow to store sterile lancets, which are accessible to a
user by making an interior panel 40 in the cap removable. Test strips may
be stored in a cartridge in the unit and dispensed one at a time by a
slider button on the side of the unit (not shown). The end of the unit
may be made removable to enable replacement of empty test strip
cartridges. Those skilled in the art will recognize many ways in which
the blood glucose monitoring system can be implemented while still
maintaining the sleek, compact appearance of the unit 10 that comprises
an aspect of the invention.

[0029]FIG. 3 shows an exemplary embodiment of an insulin injection
mechanism 50. The insulin injection mechanism includes a cap 14 as shown
in FIGS. 1A and 1B to protect the hypodermic needle 52 from damage and to
prevent inadvertent needle sticks. The cap is not shown in FIG. 3. As
with the cap 32, the cap 14 of the insulin injection mechanism fits
snugly onto the end of the housing in a manner similar to that used for
the cap 32. That is, the housing 12 presents an external shoulder 54 with
a circumferential ridge 54a. The external shoulder 54 fits into an
internal shoulder on the cap 14 (not shown) to hold the cap 14 in place
on the housing in a manner similar to that described above for the cap
32. The outside peripheral surfaces of the cap 14 and housing 12 are
flush in order to maintain the unitary appearance of the unit 10 when the
cap is in place on the housing. U.S. Pat. No. 5,728,074 mentioned above
describes various ways of implementing an insulin injection mechanism.
Any of those mechanisms, or variations thereof, can be used in the unit
10 of the present invention, and those portions of U.S. Pat. No.
5,728,074 describing insulin injection mechanisms are incorporated by
reference as if set out in full herein. Many of the other patents
discussed above also describe insulin injection mechanisms, and any of
those mechanisms can be used in the unit 10 as well. If the user has to
gain access to the interior components of the insulin injection mechanism
for any reason, such as to replace a cartridge containing plural insulin
doses, the cover 24 can be removed to provide such access.

[0030] Referring back to FIG. 1A, the side of the housing 12 opposite the
side having the insulin injection mechanism access opening 24 and the
battery compartment 26, can be considered the front of the unit. It has a
user interface that comprises two manual input devices 102 and 108 and an
LCD display 200. The manual input device 102 is a circular
touch-activated device in which each of four regions separated by
90° provide an input signal when touched by a user. Touching a
center region provides a SELECT command. The input device 108 acts a mode
switch by which the user can set a mode of operation of the device by
moving an image of a slider to the right or left. A more detailed
description concerning the layout and operation of the input devices is
provided below in connection with FIG. 5. These devices, together with
the LCD display 200, enable operation of the device as described in
detail below. These input devices can take alternate forms, such as
mechanical switches that close respective electrical circuits when
pressed. They can also have different configurations, and be located on
the unit 10 in locations other than as depicted in the accompanying
drawings. In its broadest aspects, the invention includes all manner of
input devices capable of providing the desired control functions. The LCD
display 200 is capable of displaying different screens, depending on the
input from the manual input devices or the unit's controlling software.
The LCD display can be backlit with different colors for purposes
described in more detail below. Those skilled in the art will recognize
that other types of display devices can be used within the scope of the
invention. A more complete description of the user interface is deferred
until the discussion further below of the operation of the unit 10 and
its improved manner of enabling diabetes patients to more easily and
safely manage their symptoms.

[0031]FIG. 4 shows the system components for providing the operating
functions of the unit in accordance with particular embodiments of the
invention. The unit is under the overall control of a microprocessor 300
that incorporates a read-only memory ROM storing an operating system and
executable programs that use algorithms and data provided to the unit to
determine insulin dosages and other parameters useful in managing the
patient's symptoms, and that control the operation of the various other
components of the system described just below. The microprocessor 300
also includes a random access working memory RAM to enable the
microprocessor to execute programs stored in the ROM. A clock 302 in the
housing 12 is under the control of the microprocessor 300. The clock
provides time and date information to the microprocessor for display on
the LCD display, as discussed below. The microprocessor 300 can also
condition the clock 302 to function as a timer for providing elapsed time
data to the microprocessor for purposes also discussed below.

[0032] In the present embodiment the unit 10 further includes Wi-Fi
circuitry 304 in the housing 12 and under the control of the
microprocessor 302. The Wi-Fi circuitry can communicate with remote
locations via wireless connection to the Internet if the unit 10 is
sufficiently close to a Wi-Fi router. This enables information to be sent
and received by the unit wirelessly at very high speeds. The unit 10
further includes a GPS (Global Positioning System) receiver 306 that
receives signals from a GPS satellite to indicate the global longitude
and latitude of the unit. The unit can also include Bluetooth circuitry
308 for wireless connection to a peripheral device such as a user's
cellular telephone or personal digital assistant (not shown). Finally,
the present embodiment also includes an internal cellular telephone 310
for dialing remote locations under the control of the microprocessor 300.
The cellular telephone can further include so-called 3G or 4G circuitry
for connection to the Internet when connection to a Wi-Fi router
connection cannot be made. The functions and purposes of these components
are discussed below in connection with the operation of the unit 10.

[0033] FIG. 5 is a detailed view of the front of the unit 10, showing the
layout of the manual input devices 102 and 108 and the LCD display 200.
The four regions spaced at 90° around the periphery of the
touch-activated input device 102 provide separate input functions. A MENU
"button" 102a at a nine o'clock position on the circular device 102
causes a menu of control options to be displayed on the LCD display 200.
An UP "button" 102b at twelve o'clock and a DOWN "button" 102c at six
o'clock on the device 102 enable the user to scroll through and highlight
menu choices shown on the LCD display. The center of the device 102
comprises a touch-activated SELECT "button" 102d that selects the
highlighted choice. The region at three o'clock is a DATE/TIME "button"
102e that causes the LCD display 200 to indicate the date 202 and the
time of day 204, as shown in FIG. 5. The LCD display also includes a
battery status indicator 206 that indicates in a conventional manner the
amount of battery life remaining. The unit defaults to the date/time
display in the absence of other inputs to the device 102. The mode switch
108 has an image of a slider 108a that acts as a switch "button." Unit
software maintains the slider image in a default position midway between
the right and left ends of the image display that comprises the input
device 108. A user slides the button to the right (as seen in FIG. 5) to
activate the glucose monitoring system 16 and to the left to activate the
insulin injection mechanism 50. The unit may also include a separate
button (not shown) that "locks" the devices 102 and 108 so that they
cannot be inadvertently actuated. The use of the input devices and the
LCD display to operate the unit is discussed in more detail as part of
the following explanation of how one embodiment of the unit is typically
used to manage the symptoms of a diabetes patient.

[0034] Initialization of the Unit

[0035] To perform the tasks described herein, the unit 10 requires initial
set up by inputting data from the patient's healthcare provider. In its
most basic form, this involves loading data into the ROM in the device
microprocessor 300 that will enable the programs stored therein to
calculate insulin dosages and specify treatment regimens based on the
user-patient's tested glucose level. This data can be input using a
portable USB drive (not shown) on which the necessary information has
been stored by the healthcare provider and which is then plugged into the
USB port 22, or by sending the information to the unit over the Internet
via a receiver included in the Wi-Fi circuitry 304 or the cellular
telephone circuitry 310 included in the unit.

[0036] The necessary data is loaded into the unit's ROM by the healthcare
provider so that it is available when the patient uses the unit. The data
would typically include information such as insulin dosages and types and
amounts of glucose-producing substances to be consumed based on tested
blood glucose levels, and any other data or parameters required by the
algorithms in the ROM used by the device to determine a given insulin
dosage or amount and type of glucose-producing substance to be ingested
appropriate to a patient's tested blood glucose level. The exact nature
of this data does not form a part of the present invention, and
literature such as the references already discussed above illustrate the
type of data that can be used in this regard. The data loaded into the
unit also includes at least four blood glucose levels for the particular
patient-user: [0037] L1: Threshold level for severe hypoglycemia [0038]
L2: Threshold level for mild hypoglycemia [0039] L3: Threshold level for
mild hyperglycemia [0040] L4: Threshold level for severe hyperglycemia

[0041] The description that follows of a testing/treatment/emergency
notification process using the unit of the present invention assumes that
a treatment protocol with the necessary information appropriate to the
particular patient using the unit has been stored in the unit ROM.

[0042] One way of uploading the necessary data to the unit uses the input
device 102 and the LCD display 200 under the direction of the
microprocessor 300. For example, in one possible embodiment the MENU
region 102a of the input device 102 would be touched when data was to be
uploaded to the unit 10. The microprocessor could be programmed to prompt
insertion of a USB drive into the USB port 22 if that had not already
been done, and then to cause the LCD to display a menu of prompts that a
user can scroll through using the UP and DOWN buttons 102b and 102c to
highlight displayed prompts in order. For example, a menu could include a
number of options, one of which is "INPUT DATA." The UP and DOWN buttons
would enable the user to highlight that option and activation of the
SELECT button 102d would cause the data to be uploaded into the unit. Any
other prompt menus necessary at various times during a data upload could
be displayed and chosen in the same fashion.

[0043] Another menu item could permit the user to choose the language in
which the unit will display messages and provide voice prompts during use
of the unit for blood glucose monitoring and insulin injection. For
example, one of the menu choices could be LANGUAGE, and once that menu
item is highlighted by scrolling to it using the UP or DOWN button,
touching the SELECT region 102d causes the LCD display to list the
available languages. Again, the UP or DOWN button is used to scroll to
and highlight the desired language choice, and the SELECT region 102d is
touched to select the highlighted language choice. Typically, the default
language will be English, and messages and voice prompts will be in
English unless changed.

[0044] Using the Unit for Blood Glucose Testing and Insulin Injection

[0045] FIG. 6 is a flowchart depicting the manner in which the unit 10
operates to perform a testing/treatment/emergency notification process
according to one embodiment of the invention. It will be understood that
the steps shown in the flowchart of FIG. 6 are under the control of
application software stored in the ROM in the microprocessor 300 and
executed by the microprocessor 300 in a conventional fashion. Any
suitable programming language or technique can be utilized to carry out
the steps depicted in FIG. 6 or their equivalents, and the invention is
not limited to any particular software configuration.

[0046] A patient initiates a blood glucose test in step S102 by sliding
the mode switch button image 108a to the right as seen in FIG. 5 to the
"TEST BLOOD" mode of operation. This sets a flag F to "0" in step S104
and sets a timer in step S105 to count down a sufficient time for the
user to perform a blood glucose test as described below in connection
with step S106. A suitable time period is preferably about five minutes,
but can be any appropriate time period between, say, three minutes and 10
minutes.

[0047] At the same time, the microprocessor 300 causes the LCD display 200
to display the screen 208 shown in FIG. 7. This screen includes the
battery status indicator 206, so that the user always has a visual
indication of how much charge remains in the unit's batteries. It further
includes an icon 210 that indicates the status of the blood testing
procedure, three numeric fields 212, 214 and 216, and two text fields 218
and 220. As seen in display status box D102, the blood test status icon
210 is flashing and the first text field 218 contains the message
"AWAITING BLOOD SAMPLE." The numeric fields all display the numeral "0"
and the second text field 220 is blank. (The dotted lines denoting the
numeric and text fields in FIG. 7 indicate the positions of the fields on
the display; the dotted lines are not part of the display.) A star-shaped
alarm icon 222, described in more detail below, is not visible in the
display indicated by the display status box D102. The microprocessor 300
can be further programmed to provide a voice message to the speaker 18
that repeats the message displayed in the first text field 218. The
capacity to echo a text message with a voice prompt can be an important
feature because impaired vision or even blindness can be a side effect of
diabetes.

[0048] The unit then waits at step S106 for the patient to take a blood
sample and initiate a blood glucose level test. To take a blood sample,
the patient removes the cover 32 from the blood glucose monitoring system
16 (see FIG. 2), retrieves a lancet 30 from inside the cap 32, affixes it
to the cap, and pierces a finger using the lancet 30. As described above
in connection with FIG. 2, the patient places a blood sample on the test
strip 33, which the user has extended from a cartridge within the unit
housing 12. When the blood sample reaches the glucose sensing components
within the unit 10, the icon 210 stops flashing and is lit continuously,
while the first text field 218 contains the message "TESTING GLUCOSE
LEVEL" (not shown in FIG. 6). During the time elapsed after the timer is
set in step S105, the microprocessor continuously checks to see if the
timer has timed out. This is represented by the loop including steps S106
and S108. As before, the microprocessor 300 can be programmed to provide
a voice message to the speaker 18 that repeats the message displayed in
the first text field 218. If the timer times out before the unit detects
the presence of a blood sample, the process terminates, as shown at step
S110. This causes the unit to go into a "sleep" mode to save battery
life. Any suitable manner of "waking" the device can be used. For
example, in the sleep mode the LCD display would be off, but touching
either input device 102 or 108 could cause the display of a message that
touching the DATE/TIME region 102e will activate the unit.

[0049] Blood Test Results Indicate Hypoglycemia

[0050] If the microprocessor detects a blood sample before the timer times
out, the process proceeds to step S112, which initiates an important
aspect of the invention. As noted above, the microprocessor ROM stores
data relating to normal blood glucose levels particular to the patient
using the unit, as well as certain predetermined levels that indicate
different blood glucose readings that the patient can safely tolerate. In
step S112 the microprocessor determines if the tested blood glucose level
is below the critical predetermined level L1 that indicates severe
hypoglycemia and could result in the imminent onset of diabetic coma in
this particular patient. If so, another time period is set in step S114.
At the same time, the LCD display 200 displays the blood glucose level in
the numeric fields 212, 214 and 216, and the first text field 218 now
reads "BLOOD GLUCOSE LEVEL." The display can optionally indicate the
units in which the blood glucose level is displayed, but in a preferred
embodiment the level is expressed in the standard units of mg/dL and no
indication of the units is necessary. If the blood glucose level is less
than L1, the LCD display is back lit in flashing red, the star-shaped
alarm icon 222 begins flashing red to indicate a severe hypoglycemic
condition, and the second text field 220 is changed to read "PRESS ANY
BUTTON," as seen in display status box D104. The microprocessor also
sends to the speaker 18 an audible prompt such as, "To terminate alarm
condition press any button on the unit or say "OK."

[0051] During the time elapsed after the timer is set in step S114, the
microprocessor continuously checks to see if the timer has timed out.
This is represented by the loop including steps S116 and S118. A suitable
time period is about 10 seconds, and is preferably not more than one
minute. The purpose of this time period is to give the user an
opportunity to respond in a manner that indicates that the user has not
become disoriented, or even entered a diabetic coma, because of the
indicated severe hypoglycemia detected by the blood test. If the
user-patient presses anyplace on the input device 102, or the microphone
22 picks up an audible signal that voice recognition software in the
microprocessor recognizes as "OK," before this time period expires, the
microprocessor proceeds to the next portion of the process, discussed
further below.

[0052] However, if the timer times out before the patient responds, the
unit 10 responds at step S120 with an automatic call using the unit's
internal cellular telephone 310 to call a public emergency service
provider by dialing 911 and to call a pre-subscribed emergency service
such as the Alert One® medical alert service provided by Alert One
Services, Inc., of Williamsport, Pa. The unit sends a prerecorded message
to 911 and to the subscriber service that identifies the caller, states
that he or she may be in a diabetic coma, and includes information on the
unit's location provided by the GPS receiver 306. The unit's ROM can
include software and a database for converting the unit's global
coordinates provided by the GPS receiver 306 into usable location
information, such as a street address, but the capability of converting
the coordinates into location information can also be at the call
reception location, or via a handheld device such as an Apple iPhone®
with which the unit communicates via its Bluetooth circuitry 308. In the
latter case, the call to the emergency service provider can be made by
the external device, as well. Communicating with both 911 and a private
subscriber service ensures that the patient will obtain the medical
attention necessary because of his or her severe hypoglycemia.

[0053] The automatic notification of 911 and/or an emergency subscriber
service is an important aspect of the invention. One of the objects of
the present invention is to enable a diabetic patient to maintain a
lifestyle that is as normal as possible, while still managing the
symptoms of his or her diabetes. To do that, the user must have a level
of confidence that a self-monitoring device can reduce the chances for
negative outcomes if his or her symptoms should become so severe that
they present a serious, or even life-threatening, situation. By providing
for automatic notification of an emergency service provider ("911" and/or
a subscriber service) as discussed herein, the unit 10 gives the
user-patient confidence that symptoms that are so severe that he or she
may not even be able to recognize their existence, will automatically
engender an emergency response and immediate emergency treatment or other
appropriate action. The other instances discussed below in which the unit
10 performs automatic emergency notifications achieve the same effect.

[0054] Returning to step S112, if the tested blood glucose level is higher
than the level L1, the process proceeds to step S122, where the level is
now compared to the predetermined minimum level L2 for the particular
patient for whom the unit has been set up. A blood glucose level below L2
indicates that the patient is mildly hypoglycemic and needs to increase
his or her blood glucose by ingesting a suitable blood glucose producing
substance. To that end, the microprocessor sets the LCD display 200 as
indicated in display status box D106, with the LCD steadily back lit in a
different color, such as red, to indicate a hypoglycemic condition, with
the star-shaped alarm icon 222 illuminated, and with the message "GLUCOSE
LEVEL LOW" in the second text field 220. At the same time, the
microprocessor sets another time period in step S124, for a purpose
described further below. As indicated in the figure, the process also
proceeds to step S124, after setting the flag F=1 in step S126, when the
unit detects a user response from a severely hypoglycemic patient (step
S116).

[0055] Next, the process checks the status of the flag F in step S128. If
F=1, indicating a severe hypoglycemic condition, the LCD display 200
changes to the mode shown in FIG. 8 to display a treatment regimen to the
user. This screen 230 includes a first text field 232 and a second text
field 234, corresponding to the first and second text fields of screen
208 shown in FIG. 7. The numeric fields of screen 208 are replaced by a
message field 236, which is capable of displaying treatment instructions
to the patient-user. (As with screen 208, the dotted lines in screen 230
shown in FIG. 8 denoting the text and message fields indicate the
positions of the fields and are not part of the display.) Text field 232
now reads "LOW GLUCOSE LEVEL," indicating that the patient needs to
ingest a carbohydrate-containing substance. In accordance with known
treatment protocols, the type of substance will generally be in the
nature of a sugary drink, such as a commercially available fruit juice, a
solid food containing sugar and/or other carbohydrates, or a glucose gel
available for the express use of diabetic patients. The amount of the
substance will reflect that the patient's blood glucose level is at a
dangerously low level less than L1 (see steps S112 and S126). According
to one standard protocol, the unit software causes the message field 236
to display treatment regimen instructions such as shown in display status
box D108: [0056] Drink 8 oz. sugary drink AND [0057] Eat 3 graham
crackers, OR [0058] Ingest 2 tubes glucose gel.

[0059] In addition, the second text field 234 reads "RETEST BLOOD IN 15
MIN." This provides sufficient time for the patient's blood glucose level
to respond to the ingestion of the prescribed substance(s). It will be
understood by those skilled in the art that the particular substances
listed here are representative and may be other substances within the
scope of the invention. In addition, the 15-minute waiting time is also
representative, and it too can be other time periods if deemed
appropriate for a given patient. Indeed, the substances to be consumed
and the waiting period between blood tests can be tailored to the
individual patient-user of the unit and stored in the unit ROM for
display as discussed here.

[0060] The time period set in step S124 allows for the waiting period just
discussed, that is, 15 minutes in the present embodiment of the
invention, plus an interval that will allow sufficient time to take the
next blood test. In an alternate embodiment, the unit can first set a
15-minute time period and then prompt the user to perform the next blood
test by displaying a screen similar to that shown in display status box
D102 and/or generating an audible signal such as a repeating beeping
sound. Then, another time period will be set as in step S105 with a time
period such as five minutes in which the user must perform the blood
test. In any case, the microprocessor continuously checks to see if the
timer has timed out, as represented by the loop including steps S130 and
S132.

[0061] If the patient fails to take another blood sample within the time
allotted, the unit 10 responds at step S134 with an automatic call using
the unit's internal cellular telephone 310 to the subscriber service such
as the Alert One® medical alert service discussed above. The call
identifies the caller, states that he or she is not responding as
required by his or her treatment protocol, and includes a prerecorded
message that includes information on the unit's location provided by the
GPS receiver 306. The subscriber service will then call the user to make
a judgment as to whether or not emergency service is required. A call to
911 is not made at this time since it is unlikely that the user is in
imminent danger of entering a diabetic coma considering the amount of
blood glucose producing substances that have just been ingested.

[0062] In another alternate embodiment, the microprocessor can be
programmed to await the user's confirmation that the blood sugar
producing substances have been ingested as instructed. That is, if the
protocol incorporates a first 15-minute period to allow for the ingestion
of the substances as directed by the unit, the user could be required by
a message on the LCD display 200 and/or an audible prompt to confirm that
the specified substances were consumed before the second time period
waiting for the next blood test is set. If the user does not respond as
directed, the process would go to step S120. This embodiment would
account for a severely hypoglycemic patient who was able to respond in
step S116, but nevertheless did not respond in time to the ingestion of
the directed substances to prevent disorientation or coma.

[0063] If the unit receives the results of the second blood test before
the timer times out, the process advances to step S136, where the glucose
level is again compared to L2. If the patient is still hypoglycemic
(blood glucose level<L2), the process first proceeds to step S138
where it increments the status of the flag by 1, so that F=2, and then
returns to the point where the LCD display 200 exhibits display status
box D106, with the numeric fields 212, 214 and 216 now displaying the
current glucose level. Step S124 sets the same time period a second time
and the process proceeds to step S128. Since F=2 (that is, F≠1),
step S128 directs the process to step S140, where it is determined if
F=3.

[0064] It will be appreciated that if the first blood test taken in step
S106 resulted in a blood glucose level between L1 and L2, indicating
milder hypoglycemia, the process will also reach step S140, since in that
event step S128 will detect that F=0 (that is, F≠1). Step S140 then
detects F≠3, meaning that the LCD display 200 again changes to the
mode depicted in FIG. 8. According to the treatment protocol represented
by the present embodiment, the unit's software causes the message field
236 to display the following treatment instruction, as shown in display
status box D110: [0065] Drink 4 oz. sugary drink, OR [0066] Eat 3
graham crackers, OR [0067] Ingest 1 tube glucose gel

[0068] In addition, the second text field 234 reads "RETEST BLOOD IN 15
MIN." This provides sufficient time for the patient's blood glucose level
to respond to the substance(s) ingested to raise his or her glucose
levels. The unit will now wait for the results of a second blood test, as
effected by the loop comprising steps S130 and S132. If a blood test is
not taken before the timer times out, the process proceeds to step S134,
described above.

[0069] Severely Hypoglycemic Patient after the Second Blood Test.

[0070] If the second blood test for a severely hypoglycemic patient still
indicates a hypoglycemic condition, the amount of the substances that
will raise the user's blood glucose levels is reduced from the amount
that was ingested after the first blood test. This is effected by the
status of the flag F, which was set at F=2 after the second blood test.
Step S128 now detects that F≠1 and advances the process to step
S140, which detects that F≠3. Consequently, the LCD display issues
the instruction shown in display status box D110, instructing the patient
to perform a third blood test, and then advances to step S130. If the
third blood test indicates that the patient's glucose level is still less
than L2, step S138 sets the flag status F=3 (F=2+1), and returns the
process to the point where the LCD display 200 exhibits display status
box D106, with the numeric fields 212, 214 and 216 displaying the current
glucose level. Step S124 sets the same time period again and the process
proceeds to step S128. Now, F=3 (that is, F≠1), step S128 directs
the process to step S140, which detects that F=3. This causes the unit to
proceed to step S120, which is described above. In other words, the
protocol of the present embodiment assumes that the failure of the
patient's severe hypoglycemia to respond to the ingestion of large
amounts of glucose-producing substances indicates a possible emergency
condition and warrants a call to 911.

[0071] Mildly Hypoglycemic Patient after the Second Blood Test.

[0072] If the second blood test for a more mildly hypoglycemic patient
still indicates a hypoglycemic condition, the amount of the substances
that will raise the user's blood glucose levels is increased from the
amount that was ingested after the first blood test. This is effected by
the status of the flag F, which step S138 set at F=1 after the second
blood test. Step S128 now detects that F=1 and the LCD display 200
displays the instruction in display status box D108 and waits for the
results of a third blood test, as effected by the loop comprising steps
S130 and S132. In other words, the protocol of the present embodiment
increases the amount of blood glucose producing substances to be ingested
by the patient because of his or her failure to adequately respond to the
ingestion of a smaller amount per the instruction in display status box
DUO. Assuming a third blood test is taken within the time allotted (steps
S130 and S132), the process then determines if the user's blood glucose
level is now at least L2. (If a third blood test is not taken before the
timer times out, the process proceeds to step S134, described above.)

[0073] If the third blood test indicates that the patient's glucose level
is still less than L2, step S138 sets the flag status F=2 (F=1+1). The
process returns to the point where the LCD display 200 exhibits display
status box D106, with the numeric fields 212, 214 and 216 displaying the
current glucose level.

[0074] The patient now can ingest additional blood glucose containing
substance(s) and take a fourth blood test, since step S140 will detect
that the flag status F≠3. However, the patient may decide based on
personal experience that the glucose level already achieved (as displayed
in display status box D106) is acceptable, and elect not to take a fourth
blood test. In that event, the timer times out, the unit calls the
subscriber service (step S134), and the patient can confirm to the caller
that he or she has an acceptable glucose level and does not need
assistance. However, if the user elects to take a fourth blood test, step
S136 again determines if the tested glucose level is still below L2. If
so, step S138 sets the flag status F=3 (F=2+1), and when the process
reaches step S140, it will detect that flag status and proceed to step
S120, as discussed above. In other words, this particular protocol
assumes that the patient requires emergency assistance since the repeated
ingestion of blood glucose producing substances has not remedied a
detected hypoglycemic condition.

[0075] If at any time, step S136 detects a blood glucose level that is not
less than L2, the process proceeds to step S142, where the flag status F
is set to F=0, and then proceeds to step S144, which determines if the
user's blood glucose level is not above L3, thus indicating that is in
the normal range between L2 and L3. If so, the process terminates, as
indicated in step S146 (similar to step S110). If step S144 indicates
that the user's blood glucose level exceeds L3, it indicates a
hyperglycemic condition, possibly requiring the administration of an
insulin injection. In addition, if the first blood test (step S106)
indicates a blood glucose level that exceeds L2, the process also
proceeds to step S144 (see steps S112 and S122). Step S146 can be
accompanied by a message on the LCD display 200 indicating that the
user's blood glucose level is normal, with the background of the display
lit in steady or flashing green, to provide an immediately recognizable
indication that the user's glucose level is acceptable.

[0076] Blood Test Results Indicate Hyperglycemia

[0077] If step S144 indicates that the user's blood glucose level is above
L3, the next step S148 determines if the level is above L4, thus
indicating more severe hyperglycemia. If so, the process proceeds to step
S150 to check the status of the flag F. Since the flag F was set F=0
(step S104 or step S142), the process proceeds to step S152. At the same
time, the LCD display 200 displays the blood glucose level in the numeric
fields 212, 214 and 216, and the first text field 218 now reads "BLOOD
GLUCOSE LEVEL." The LCD display is back lit in flashing red, the
star-shaped alarm icon 222 begins flashing red to indicate a severe
hyperglycemic condition, and the second text field 220 is changed to read
"PRESS ANY BUTTON," as seen in display status box D112. The
microprocessor also sends to the speaker 18 an audible prompt such as "To
terminate alarm condition press any button on the unit or say `OK.`"

[0078] During the time elapsed after the timer is set in step S152, the
microprocessor continuously checks to see if the timer has timed out.
This is represented by the loop including steps S154 and S156. A suitable
time period is preferably about 10 seconds, and is preferably not more
than one minute. The purpose of this time period is to give the user an
opportunity to respond in a manner that indicates that the user has not
become disoriented because of the indicated severe hyperglycemia detected
by the blood test. If the user-patient presses any place on the input
device 102, or the microphone 22 picks up an audible signal that voice
recognition software in the microprocessor recognizes as "OK," before the
time period expires, the microprocessor proceeds to the next portion of
the process, which is discussed further below.

[0079] However, if the timer times out before the patient responds, the
unit 10 responds at step S158 with an automatic call using the unit's
internal cellular telephone 310 to 911 and to the subscriber service.
These calls correspond to the calls described above in connection with
step S120. That is, the unit sends a prerecorded message to 911 and to
the subscriber service that identifies the caller, states that he or she
is severely hyperglycemic, and includes information on the unit's
location provided by the GPS receiver 306, as discussed above.

[0080] If the user has responded before the time period set in step S152
expires, the process proceeds to step S160, where the status of the flag
is checked to determine if F=1. The process also proceeds to step S160 if
the user's blood glucose level is not greater than L4 as determined in
step S148. In either event, since F=0 (F≠1), the process proceeds
to step S162 where a time period is set. At the same time, the unit sets
the LCD display 200 as shown in display status box D114, with the LCD
back lit in red to indicate an abnormal condition (in this case,
hyperglycemia), with the star-shaped alarm icon 222 illuminated, and with
the message "GLUCOSE LEVEL HIGH" in the second text field 220. The unit
then awaits for the user to administer an insulin injection within the
time period set in step S162. This is indicated by the loop including
steps S164 and S166, during which the unit continuously checks to see if
an insulin injection has been administered using the unit's insulin
injection mechanism described above. The display screen 230 in FIG. 8 can
be used at this point to indicate that the prescribed treatment regimen
is an insulin injection (not shown).

[0081] If the time period times out before an insulin injection is
detected, the unit places a call to the subscriber service in step S168.
This call is similar in nature to the call placed in step S158. That is,
since the patient responded if severe hyperglycemia was detected in step
S148, or alternatively the patient is only mildly hyperglycemic as per
step S144, the protocol of the present embodiment assumes that a
life-threatening situation is not present. Accordingly, the subscriber
service will typically telephone the user to determine if he or she is
fully aware of the condition and has voluntarily chosen not to take
action. In other words, this protocol judges that a call to 911 for
immediate emergency assistance is not warranted.

[0082] Administering an Insulin Injection

[0083] To activate the insulin injection mechanism 50, the patient moves
the mode switch slider image 108a on the unit 10 to the left as seen in
FIG. 5 to the "INJECT INSULIN" mode of operation. The microprocessor ROM
contains an algorithm that uses the patient's blood glucose reading, the
time elapsed since the previous insulin injection, and other pertinent
information or parameters, to calculate the proper insulin dose. When the
results of a blood glucose test are available (see above), and the mode
switch button 108a is in the INJECT INSULIN position, the insulin dose
calculated by the algorithm is displayed (not shown in the figures) in
the numeric fields 232, 234 and 236 depicted in FIG. 7 in standard dose
units of 0.01 cc each.

[0084] The UP and DOWN buttons (see FIG. 5) can be used by the patient to
change the amount of insulin to be injected. However, after the unit sets
the dosage amount an attempt by the user to change it with the UP or DOWN
button will trigger the unit's "dose lock" feature, which causes the LCD
display to display a prompt, such as "ARE YOU SURE YOU WANT TO CHANGE
DOSAGE?" (not shown). In order to effect any change in the dosage
calculated by the unit's algorithm, the user must touch or press the
SELECT button 102d to override the dose lock feature. This dose lock
feature helps to prevent injection of inappropriate amounts of insulin by
requiring the patient to confirm that he or she wants to override the
dosage calculated by the unit. The healthcare community has recently
begun to focus more strongly on the potential for medical errors in many
environments to have severe adverse effects on patients. The unit 10's
dose lock feature provides an effective way to prevent the occurrence of
serious insulin dosage errors in the environment of diabetes patients'
self-monitoring and self-treatment of their symptoms.

[0085] Once the dosage amount has been set (either automatically by the
unit's algorithm or as manually adjusted by the patient after overriding
the dose lock), the patient presses the SELECT button 102d, which changes
the display so that the first and third numeric fields 232 and 236 are
blank, the second numeric field 234 displays a "5," the first text field
238 displays the message "AWAITING INJECTION," and the second text field
240 contains the message "INSERT NEEDLE" (not shown in the figures). The
microprocessor 300 can be programmed to provide a voice message to the
speaker 18 that repeats the message displayed in the second text field to
provide a voice prompt to administer the injection.

[0086] If the patient has not done so already, he or she removes the cap
14 to expose the hypodermic needle 52 and inserts the needle at an
appropriate location to perform an intramuscular injection of insulin.
The insulin injection mechanism preferably includes a sensor that senses
when the needle 52 has penetrated the patient's skin and begins a
countdown in one-second intervals. The second numeric field 234
accordingly decrements from "5" to "0," during which time the injection
mechanism administers the prescribed insulin dosage that was previously
displayed. The speaker 18 may accompany the visual countdown on the
display with an audible countdown. When the count reaches "0," the second
text field displays the message "REMOVE NEEDLE" (not shown in the
figures) and the same message is repeated audibly by the speaker 18. When
the needle is removed, the injection mechanism provides a signal to the
microprocessor indicating a completed insulin injection, which in turn
triggers a positive response in step S164.

[0087] The time period set in step S162 should be of sufficient duration
to permit the user to administer an insulin injection according to this
description. A suitable time period will preferably be about five
minutes, but can be any appropriate time period between say, three
minutes and 10 minutes. If the unit detects an insulin injection before
the time period expires, the LCD display 200 changes to the screen shown
in display status box D116. It shows the detected blood glucose level as
in display status box D114, and the second text field 234 in FIG. 7 reads
"RETEST BLOOD IN 15 MIN." Next, the flag status is set to F=1 in step
S170 and another time period is set to permit the user to complete the
instructed blood test. The process then proceeds to step S174 to await
receipt of a blood sample within the allotted time, as represented by the
loop containing steps S174 and S176. If no blood test is detected within
the allotted time, the unit proceeds to step S168, in which the unit
places an automatic call to the emergency service provider so that it can
be confirmed that the user is not in danger. These steps S174, S176, and
S168 are analogous to steps S130, S132, and S134 discussed above, and the
comments relating to that part of the process and possible alternate
embodiments, such as providing separate time periods for the waiting
period and the blood testing operation, apply equally here.

[0088] In an alternate embodiment, the user manually controls the insulin
injection using the input device 102. In this embodiment, moving the mode
switch 108 to the INJECT INSULIN position activates the input device 102
to permit the user to confirm needle insertion and the completion of an
injection. That is, instead of having a sensor that senses when the
needle has penetrated the user's skin, the user simply presses any place
on the input device 102 to confirm that the unit is in position to
administer the desired insulin injection. Likewise, once the injection is
complete and the user has withdrawn the needle, pressing any place on the
input device signals to the unit software that an insulin injection is
complete. While not as independent of user input as the embodiment
described above, an this alternate embodiment will undoubtedly prove less
expensive to manufacture and thus be more attractive economically for
some users.

[0089] If a blood sample is taken within the allotted time, the process
returns to step S144. If the user's blood glucose level is within the
normal range, the process ends at step S146. However, if the patient is
still hyperglycemic after the insulin injection, the process proceeds to
step S148 to determine if the hyperglycemia is severe (blood glucose
greater than L4). If so, step S150 determines that the flag status is F=1
(step S170), and places an automatic call to the subscriber service in
step S178. This call will typically include information on the patient's
blood glucose level and indicate that an insulin injection has been
administered within the preceding 15 minutes. The subscriber service will
place a call to the user to confirm that he or she is not in danger.

[0090] If the patient's blood glucose level is only mildly elevated (that
is, greater than L3 but not greater than L4), the process proceeds to
step S160, which detects that the flag status is F=1 (step S170). In this
case, the unit terminates the process in step S180.

[0091] One of the advantages of being able to store and guide the user
through a detailed treatment protocol like that depicted in FIG. 6 and
described above is that it enables matching a patient's self-treatment
protocol to inpatient treatment protocols. For example, if a detailed
treatment protocol is determined for a particular diabetes patient in an
inpatient setting, this protocol can be duplicated by appropriate
programming of the microprocessor of a unit according to the invention.
This streamlines the user's care and increases the utility of the unit
because the user-patient's outpatient treatment protocol (using the unit
10) and established inpatient treatment protocol will be essentially the
same. This can be expected to reduce the number of times the unit
performs emergency notifications, and likewise reduce the number of times
a user must be taken to a hospital emergency room because his or her
symptoms have become too severe for self-treatment.

[0092] Data Recording and Utilization

[0093] Another aspect of the invention involves storage in the
microprocessor's ROM of complete information regarding the timing and
results of the blood glucose testing, times and amounts of blood glucose
producing substances ingested, times and amounts of insulin injections,
calls to 911 and the subscriber service, or any other aspect of the
process just described. For example, the unit can record the time of
every glucose test and the resulting glucose level. It can also record
whether any alarm condition was encountered. Likewise, the unit can
further store each calculated insulin dosage, as well as the actual
insulin dosage administered by the patient and time of administration.

[0094] The patient's healthcare provider can download this information
into a central computer using the USB port 22 or a Wi-Fi connection, and
employ it for various reasons. For example, one important use of this
information is to make any necessary adjustments to the patient's
treatment protocol, which can then be uploaded to the unit as discussed
above. The same information, collected from numerous patients, can be
used for public health purposes by converting it to statistical
information on diabetes treatment.

[0095] This data can also have significant commercial uses. For example,
diabetes is the subject of frequent clinical trials, which require
judicious selection of test subjects to match the particular
characteristic of the disease being studied in a given trial. This often
requires detailed knowledge of the treatment history of a potential
subject, as well as his or her responsiveness to any given treatment
regimen. The storage of all of the above information regarding a user of
the unit 10 greatly facilitates screening and selection of possible
subjects for such clinical trials. Another possible use of the recorded
data would be to target training and informational materials specific to
particular aspects of the treatment and symptoms of groups of users. For
example, a given group of users might be identified as having a certain
class of symptoms about which recent research has discovered new
information. A healthcare provider could offer as a service the
transmission of messages (via cellular telephone) to those users whose
treatment profiles warrant. The message could be in the form of a notice
for display on the LCD displays of these users' units that additional
information they could find helpful or useful, or even critical, can be
found at a certain website.

[0096] Those skilled in the art will recognize that other variations on
the disclosed embodiments that would fall within the scope of the
invention are possible. For example, even though the input devices 102
and 106 provide a sleek, streamlined appearance to the unit, mechanical
switches can be used to perform the same functions. In another variation,
the testing/treatment history of a user can be downloaded via a bar code
displayed on the LCD display 200 rather than by using an external USB
drive or an Internet connection. In this variation, the unit software can
include an algorithm that converts recorded data into a bar code format
that is then displayed on the LCD display. Scanning the bar code
transfers the information to the scanning device. If necessary, the
information can be contained in multiple bar code displays, which are
then scanned in turn.

[0097] In another alternate embodiment, the unit can include a removable
USB storage device on which the data is recorded. This will facilitate
manipulation and transportation of the recorded information. For example,
it will eliminate an intermediate step in which the unit must be
connected to a computer through a USB port, as discussed. It will also
enable a user to mail or otherwise transport the recorded data to a
healthcare provider, for those users not comfortable with transmitting
data over the Internet, as well as eliminating the need to visit the
healthcare provider simply to have the recorded data downloaded onto a
computer at the provider's location. If a removable USB storage device is
used, the unit can be provided with multiple such devices so that the
user has a supply on hand.

[0098] Those skilled in the art will readily recognize that only selected
preferred embodiments of the invention have been depicted and described,
and it will be understood that various changes and modifications can be
made other than those specifically mentioned above without departing from
the spirit and scope of the invention, which is defined solely by the
claims that follow.